Vessel sealing forceps

ABSTRACT

A removable electrode assembly for use in combination with a forceps having opposing end effectors and a handle for effecting movement of the end effectors relative to one another. The electrode assembly includes a housing which is removably engageable with the forceps and a pair of electrodes which are attachable to a distal end of the housing. The electrodes are removably engageable with the end effectors of the forceps such that the electrodes reside in opposing relation relative to one another. The electrode assembly also includes a cover plate which is removably attachable to the housing and at least one stop member for controlling the distance between the opposing electrodes. The stop member is selectively engageable with the electrodes.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a Continuation application that claims the benefitof and priority to U.S. application Ser. No. 11/489,319 filed Jul. 19,2006, which is a continuation of U.S. application Ser. No. 10/474,227filed on Oct. 3, 2003 by Tetzlaff et al., now U.S. Pat. No. 7,118,570,which is a national stage application of PCT/US01/11218 filed on Apr. 6,2001, and a continuation-in-part of U.S. application Ser. No. 09/425,696filed on Oct. 22, 1999 by Tetzlaff et al., now U.S. Pat. No. 6,511,480,which is a continuation-in-part of U.S. application Ser. No. 09/178,027filed Oct. 23, 1998 by Tetzlaff et al., now U.S. Pat. No. 6,277,117, anda continuation-in-part of U.S. application Ser. No. 09/177,950 filedOct. 23, 1998 by Frazier et al., now abandoned, the entire contents ofall of these applications are hereby incorporated by reference.

BACKGROUND

The present disclosure relates to electrosurgical forceps used for opensurgical procedures and/or laparoscopic surgical procedures. Moreparticularly, the present disclosure relates to a bipolar forceps havinga disposable electrode assembly for sealing, cauterizing,coagulating/desiccating and/or cutting vessels and vascular tissue.

Technical Field

A hemostat or forceps is a simple plier-like tool which uses mechanicalaction between its jaws to constrict tissue and is commonly used in opensurgical procedures to grasp, dissect and/or clamp tissue.Electrosurgical forceps utilize both mechanical clamping action andelectrical energy to effect hemostasis by heating the tissue and bloodvessels to coagulate, cauterize, cut and/or seal tissue.

By utilizing an electrosurgical forceps, a surgeon can either cauterize,coagulate/desiccate and/or cut tissue and/or simply reduce or slowbleeding, by controlling the intensity, frequency and duration of theelectrosurgical energy applied to the tissue. Generally, the electricalconfiguration of electrosurgical forceps can be categorized in twoclassifications: 1) monopolar electrosurgical forceps; and 2) bipolarelectrosurgical forceps.

Monopolar forceps utilize one active electrode associated with theclamping end effector and a remote patient return electrode or pad whichis attached externally to the patient. When the electrosurgical energyis applied, the energy travels from the active electrode, to thesurgical site, through the patient and to the return electrode.

Bipolar electrosurgical forceps utilize two generally opposingelectrodes which are disposed on the inner opposing surfaces of endeffectors and which are both electrically coupled to an electrosurgicalgenerator. Each electrode is charged to a different electric potential.Since tissue is a conductor of electrical energy, when the effectors areutilized to clamp or grasp tissue therebetween, the electrical energycan be selectively transferred through the tissue.

The process of coagulating small vessels is fundamentally different thanvessel sealing. For the purposes herein the term coagulation is definedas a process of desiccating tissue wherein the tissue cells are rupturedand dried. Vessel sealing is defined as the process of liquefying thecollagen in the tissue so that it cross-links and reforms into a fusedmass. Thus, coagulation of small vessels is sufficient to close them,however, larger vessels need to be sealed to assure permanent closure.

In order to effect a proper seal with larger vessels, two predominantmechanical parameters must be accurately controlled—the pressure appliedto the vessel and the gap between the electrodes both of which affectthickness of the sealed vessel. More particularly, accurate applicationof the pressure is important to oppose the walls of the vessel, toreduce the tissue impedance to a low enough value that allows enoughelectrosurgical energy through the tissue, to overcome the forces ofexpansion during tissue heating and to contribute to the end tissuethickness which is an indication of a good seal. In some instances afused vessel wall is optimum between 0.001 and 0.006 inches. Below thisrange, the seal may shred or tear and above this range the lumens maynot be properly or effectively sealed.

Numerous bipolar electrosurgical forceps have been proposed in the pastfor various open surgical procedures. However, some of these designs maynot provide uniformly reproducible pressure to the blood vessel and mayresult in an ineffective or non-uniform seal. For example, U.S. Pat. No.2,176,479 to Willis, U.S. Pat. Nos. 4,005,714 and 4,031,898 toHiltebrandt, U.S. Pat. Nos. 5,827,274, 5,290,287 and 5,312,433 to Boebelet al., U.S. Pat. Nos. 4,370,980, 4,552,143, 5,026,370 and 5,116,332 toLottick, U.S. Pat. No. 5,443,463 to Stern et al., U.S. Pat. No.5,484,436 to Eggers et al. and U.S. Pat. No. 5,951,549 to Richardson etal., all relate to electrosurgical instruments for coagulating, cuttingand/or sealing vessels or tissue. However, some of these designs may notprovide uniformly reproducible pressure to the blood vessel and mayresult in an ineffective or non-uniform seal.

Many of these instruments include blade members or shearing memberswhich simply cut tissue in a mechanical and/or electromechanical mannerand are relatively ineffective for vessel sealing purposes. Otherinstruments rely on clamping pressure alone to procure proper sealingthickness and are not designed to take into account gap tolerancesand/or parallelism and flatness requirements which are parameters which,if properly controlled, can assure a consistent and effective tissueseal. For example, it is known that it is difficult to adequatelycontrol thickness of the resulting sealed tissue by controlling clampingpressure alone for either of two reasons: 1) if too much force isapplied, there is a possibility that the two poles will touch and energywill not be transferred through the tissue resulting in an ineffectiveseal; or 2) if too low a force is applied, a thicker less reliable sealis created.

It has also been found that cleaning and sterilizing many of the priorart bipolar instruments is often impractical as electrodes and/orinsulation can be damaged. More particularly, it is known thatelectrically insulative materials, such as plastics, can be damaged orcompromised by repeated sterilization cycles.

Thus, a need exists to develop a bipolar forceps which can seal vesselsand tissue consistently and effectively and which will not be damaged bycontinued use and cleaning.

SUMMARY

The present disclosure relates to a removable electrode assembly for usewith a forceps having opposing end effectors and a handle for effectingrelative movement of the end effectors with respect to one another. Theelectrode assembly includes a cover plate having at least one portionwhich is removably engageable with at least a portion of the forceps andan electrode housing having at least one portion which is removablyengageable with at least a portion of the forceps. A pair of electrodesattaches to a distal end of the housing. Preferably, the electrodes areremovably engageable with the end effectors of the forceps such that theelectrodes are disposed in opposing relation to one another. Theinstrument also includes at least one stop member which controls thedistance between the opposing electrodes. Preferably, the stop membersbeing selectively engageable with the electrodes. The electrode assemblycan be employed with both open surgical procedures as well aslaparoscopic surgical procedures.

In one embodiment, the electrodes include an electrically conductivesealing surface and an insulating substrate and the stop member isremovably attached to the insulating substrate. Preferably, theinsulating substrate of each of the electrodes includes at least onemechanical interface, e.g., detent, for engaging a complimentarymechanical interface, e.g., notch, disposed on the corresponding endeffector of the forceps.

In another embodiment, the substrate includes at least one detent andthe mechanical interface of the corresponding end effector includes atleast one complimentary key-like socket for slideably and securelyreceiving the detent.

In yet another embodiment, the stop member is attached to at least oneof the electrodes by thermal spraying and protrudes about 0.001 inchesto about 0.005 inches from the inner facing surface of the jaw member.Preferably, the stop member protrudes about 0.002 inches to about 0.003inches from the inner facing surface of the jaw member.

Another embodiment of the present disclosure relates to a bipolarelectrosurgical instrument which includes a forceps having opposing endeffectors and a handle for effecting relative movement of the endeffectors with respect to one another and an electrode assembly which isremovably attached to the forceps. The electrode assembly includes apair of opposing electrodes attached to a distal end thereof which areremovably engageable with one of the end effectors such that theelectrodes reside in opposing relation to one another. At least one stopmember which is selectively engageable with the electrodes controls thedistance between the opposing electrodes.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the subject instrument are described herein withreference to the drawings wherein:

FIG. 1 is a perspective view of a bipolar forceps according to thepresent disclosure;

FIG. 2 is an enlarged, perspective view of a distal end of the bipolarforceps shown in FIG. 1;

FIG. 3 is a perspective view with parts separated of the forceps shownin FIG. 1;

FIG. 4 is an enlarged, side view of a disposable electrode assembly ofFIG. 1 shown without a cover plate;

FIG. 5 is an enlarged, perspective view of a distal end of thedisposable electrode assembly of FIG. 4;

FIG. 6 is a perspective view with parts separated of an upper electrodeof the disposable electrode assembly of FIG. 5;

FIG. 7 is a perspective view with parts separated of a lower electrodeof the disposable electrode assembly of FIG. 5;

FIG. 8 is a perspective view of the forceps of the present disclosureshowing the operative motion of the forceps to effect sealing of atubular vessel;

FIG. 9 is an enlarged, partial perspective view of a sealing site of atubular vessel;

FIG. 10 is a longitudinal cross-section of the sealing site taken alongline 10-10 of FIG. 9;

FIG. 11 is a longitudinal cross-section of the sealing site of FIG. 9after separation of the tubular vessel;

FIG. 12 is a perspective view of another embodiment of the presentdisclosure;

FIG. 13 is an exploded view of the embodiment of FIG. 12;

FIG. 14 is an enlarged exploded view of a working end of the embodimentof FIGS. 12 and 13;

FIG. 15A-15C show various views of another embodiment according to thepresent disclosure showing stop members which are configured as plugs toselectively attach to inner facing surfaces of the jaw members; and

FIG. 16A-16B show various views of another embodiment according to thepresent disclosure wherein the electrode assembly engages the forceps ina slide-like manner.

DETAILED DESCRIPTION

Referring now to FIGS. 1-3, a bipolar forceps 10 for use with openand/or laparoscopic surgical procedures includes a mechanical forceps 20and an electrode assembly 21. In the drawings and in the descriptionwhich follows, the term “proximal”, as is traditional, will refer to theend of the forceps 10 which is closer to the user, while the term“distal” will refer to the end which is further from the user.

Mechanical forceps 20 includes first and second members 9 and 11 whicheach have an elongated shaft 12 and 14, respectively. Shafts 12 and 14each include a proximal end 13 and 15 and a distal end 17 and 19,respectively. Each proximal end 13, 15 of each shaft portion 12, 14includes a handle member 16 and 18 attached thereto to allow a user toeffect movement of at least one of the shaft portions 12 and 14 relativeto one another. Extending from the distal end 17 and 19 of each shaftportion 12 and 14 are end effectors 22 and 24, respectively. The endeffectors 22 and 24 are movable relative to one another in response tomovement of handle members 16 and 18.

Preferably, shaft portions 12 and 14 are affixed to one another at apoint proximate the end effectors 22 and 24 about a pivot 25 such thatmovement of the handles 16 and 18 impart movement of the end effectors22 and 24 from an open position wherein the end effectors 22 and 24 aredisposed in spaced relation relative to one another to a clamping orclosed position wherein the end effectors 22 and 24 cooperate to grasp atubular vessel 150 therebetween (see FIG. 8). It is envisioned thatpivot 25 has a large surface area to resist twisting and movement offorceps 10 during operation. Clearly, the forceps 10 can be designedsuch that movement of one or both of the handles 16 and 18 will only,cause one of the end effectors, e.g., 22, to move with respect to theother end effector, e.g., 24.

As best seen in FIG. 3, end effector 24 includes an upper or first jawmember 44 which has an inner facing surface 45 and a plurality ofmechanical interfaces disposed thereon which are dimensioned toreleasable engage a portion of a disposable electrode assembly 21 whichwill be described in greater detail below. Preferably, the mechanicalinterfaces include sockets 41 which are disposed at least partiallythrough inner facing surface 45 of jaw member 44 and which aredimensioned to receive a complimentary detent attached to upperelectrode 120 of the disposable electrode assembly 21. While the termsocket is used herein, it is contemplated that either a male or femalemechanical interface may be used on jaw member 44 with a matingmechanical interface disposed on the disposable electrode assembly 21.

In some cases, it may be preferable to manufacture mechanical interfaces41 along another side of jaw member 44 to engage a complimentarymechanical interface of the disposable electrode assembly 21 in adifferent manner, e.g., from the side. Jaw member 44 also includes anaperture 67 disposed at least partially through inner face 45 of endeffector 24 which is dimensioned to receive a complimentary guide pin124 disposed on electrode 120 of the disposable electrode assembly 21.

End effector 22 includes a second or lower jaw member 42 which has aninner facing surface 47 which opposes inner facing surface 45.Preferably, jaw members 45 and 47 are dimensioned generallysymmetrically, however, in some cases it may be preferable tomanufacture the two jaw members 42 and 44 asymmetrically depending upona particular purpose. In much the same fashion as described above withrespect to jaw member 44, jaw member 42 also includes a plurality ofmechanical interfaces or sockets 43 disposed thereon which aredimensioned to releasable engage a complimentary portion disposed on anelectrode 110 of the disposable electrode assembly 21 as describedbelow. Likewise, jaw member 42 also includes an aperture 65 disposed atleast partially through inner face 47 which is dimensioned to receive acomplimentary guide pin 126 (see FIG. 4) disposed on electrode 110 ofthe disposable electrode assembly 21.

Preferably, shaft members 12 and 14 of the mechanical forceps 20 aredesigned to transmit a particular desired force to the opposing innerfacing surfaces 47 and 45 of the of the jaw members 22 and 24,respectively, when clamped. In particular, since the shaft members 12and 14 effectively act together in a spring-like manner (i.e., bendingthat behaves like a spring), the length, width, height and deflection ofthe shaft members 12 and 14 will directly effect the overall transmittedforce imposed on opposite jaw members 42 and 44. Preferably, jaw members22 and 24 are more rigid than the shaft members 12 and 14 and the strainenergy stored in the shaft members 12 and 14 provides a constant closureforce between the jaw members 42 and 44.

Each shaft member 12 and 14 also includes a ratchet portion 32 and 34.Preferably, each ratchet, e.g., 32, extends from the proximal end 13 ofits respective shaft member 12 towards the other ratchet 34 in agenerally vertically aligned manner such that the inner facing surfacesof each ratchet 32 and 34 abut one another when the end effectors 22 and24 are moved from the open position to the closed position. Each ratchet32 and 34 includes a plurality of flanges 31 and 33, respectively, whichproject from the inner facing surface of each ratchet 32 and 34 suchthat the ratchets 32 and 34 can interlock in at least one position. Inthe embodiment shown in FIG. 1, the ratchets 32 and 34 interlock atseveral different positions. Preferably, each ratchet position holds aspecific, i.e., constant, strain energy in the shaft members 12 and 14which, in turn, transmit a specific force to the end effectors 22 and 24and, thus, the electrodes 120 and 110. A design without a ratchet systemor similar system would require the user to hold the jaw members 42 and44 together by applying constant force to the handles 16 and 18 whichmay yield inconsistent results.

In some cases it may be preferable to include other mechanisms tocontrol and/or limit the movement of the jaw members 42 and 44 relativeto one another. For example, a ratchet and pawl system could be utilizedto segment the movement of the two handles into discrete units whichwill, in turn, impart discrete movement to the jaw members 42 and 44relative to one another.

Preferably, at least one of the shaft members, e.g., 14, includes a tang99 which facilitates manipulation of the forceps 20 during surgicalconditions as well as facilitates attachment of electrode assembly 21 onmechanical forceps 20 as will be described in greater detail below.

As best seen in FIGS. 2, 3 and 5, disposable electrode assembly 21 isdesigned to work in combination with mechanical forceps 20. Preferably,electrode assembly 21 includes housing 71 which has a proximal end 77, adistal end 76 and an elongated shaft plate 78 disposed therebetween. Ahandle plate 72 is disposed near the proximal end 77 of housing 71 andis sufficiently dimensioned to releasably engage and/or encompass handle18 of mechanical forceps 20. Likewise, shaft plate 78 is dimensioned toencompass and/or releasably engage shaft 14 and pivot plate 74 disposednear the distal end 76 of housing 71 is dimensioned to encompass pivot25 and at least a portion of distal end 19 of mechanical forceps 20. Itis contemplated that the electrode assembly 21 can be manufactured toengage either the first or second members 9 and 11 of the mechanicalforceps 20 and their respective component parts 12, 16 or 14, 18,respectively.

In the embodiment shown in FIG. 2, handle 18, shaft 14, pivot 25 and aportion of distal end 19 are all dimensioned to fit into correspondingchannels located in housing 71. For example, a channel 139 isdimensioned to receive handle 18, a channel 137 is dimensioned toreceive shaft 14 and a channel 133 is dimensioned to receive pivot 25and a portion of distal end 19.

Electrode assembly 21 also includes a cover plate 80 which is alsodesigned to encompass and/or engage mechanical forceps 20 in a similarmanner as described with respect to the housing 71. More particularly,cover plate 80 includes a proximal end 85, a distal end 86 and anelongated shaft plate 88 disposed therebetween. A handle plate 82 isdisposed near the proximal end 85 and is preferably dimensioned toreleasable engage and/or encompass handle 18 of mechanical forceps 20.Likewise, shaft plate 88 is dimensioned to encompass and/or releasableengage shaft 14 and a pivot plate 94 disposed near distal end 86 isdesigned to encompass pivot 25 and distal end 19 of mechanical forceps20. Preferably, handle 18, shaft 14, pivot 25 and distal end 19 are alldimensioned to fit into corresponding channels (not shown) located incover plate 80 in a similar manner as described above with respect tothe housing 71.

As best seen with respect to FIGS. 3 and 4, housing 71 and cover plate80 are designed to engage one another over first member 11 of mechanicalforceps 20 such that first member 11 and its respective component parts,e.g., handle 18, shaft 14-, distal end 19 and pivot 25, are disposedtherebetween. Preferably, housing 71 and cover plate 80 include aplurality of mechanical interfaces disposed at various positions alongthe interior of housing 71 and cover plate 80 to effect mechanicalengagement with one another. More particularly, a plurality of sockets73 are disposed proximate handle plate 72, shaft plate 78 and pivotplate 74 of housing 71 and are dimensioned to releasably engage acorresponding plurality of detents 83 extending from cover plate 80. Itis envisioned that either male or female mechanical interfaces or acombination of mechanical interfaces may be disposed within housing 71with mating mechanical interfaces disposed on or within cover plate 80.

As best seen with respect to FIGS. 5-7, the distal end 76 of electrodeassembly 21 is bifurcated such that two prong-like members 103 and 105extend outwardly therefrom to support an electrode 110 and 120,respectively. More particularly, electrode 120 is affixed at an end 90of prong 105 and electrode 110 is affixed at an end 91 of prong 103. Itis envisioned that the electrodes 110 and 120 can be affixed to the ends91 and 90 in any known manner such as, e.g., frictional or snap-fitengagement.

A pair of wires 60 and 62 are connected to the electrodes 120 and 110,respectively, as best seen in FIGS. 4 and 5. Preferably, wires 60 and 62are bundled together and form a wire bundle 28 which runs from aterminal connector 30 (see FIG. 3), to the proximal end 77 of housing71, along the interior of housing 71, to distal end 76. Wire bundle 28is separated into wires 60 and 62 proximate distal end 76 and the wires60 and 62 are connected to each electrode 120 and 110, respectively. Insome cases it may be preferable to capture the wires 60 and 62 or thewire bundle 28 at various pinch points along the inner cavity of theelectrode assembly 21 and enclosing the wires 60 and 62 within electrodeassembly 21 by attaching the cover plate 80.

This arrangement of wires 60 and 62 is designed to be convenient to theuser so that there is little interference with the manipulation ofbipolar forceps 10. As mentioned above, the proximal end of the wirebundle 28 is connected to a terminal connector 30, however, in somecases it may be preferable to extend wires 60 and 62 to anelectrosurgical generator (not shown). Alternatively, wires 60 and 62can remain separated and extend along the first and second members 9 and11.

As best seen in FIG. 6, electrode 120 includes an electricallyconductive seal surface 126 and an electrically insulative substrate 121which are attached to one another by snap-fit engagement or some othermethod of assembly, e.g., substrate 121 is overmolded to capture theelectrically conductive seal surface 126. Preferably, substrate 121 ismade from an injection molded plastic material and is shaped tomechanically engage a corresponding socket 41 located in jaw member 44of end effector 24. The substrate 121 not only insulates the electriccurrent but it also aligns electrode 120 both of which contribute to theseal quality and consistency. For example, by overmolding the conductivesurface 126 to the substrate 121, the alignment and thickness of theelectrode 120 can be controlled.

Preferably, substrate 121 includes a plurality of bifurcated detents 122which are shaped to compress during insertion into sockets 41 and expandand releasably engage sockets 41 after insertion. It is envisioned thatsnap-fit engagement of the electrode 120 and the jaw member 44 willaccommodate a broader range of manufacturing tolerances. Substrate 121also includes an alignment or guide pin 124 which is dimensioned toengage aperture 67 of jaw member 44.

Conductive seal surface 126 includes an wire crimp 145 designed toengage the distal end 90 of prong 105 of electrode assembly 21 andelectrically engage a corresponding wire connector affixed to wire 60located within electrode assembly. Seal surface 126 also includes anopposing face 125 which is designed to conduct an electrosurgicalcurrent to a tubular vessel or tissue 150 when it is held thereagainst.

Electrode 110 includes similar elements for insulating and conductingelectrosurgical current to tissue 150. More particularly, electrode 110includes an electrically conductive seal surface 116 and an electricallyinsulative substrate 111 which are attached to one another by snap-fitengagement or some other method of assembly. Substrate 111 includes aplurality of bifurcated detents 112 and an alignment pin 126 (see FIG.4) which are dimensioned to engage a corresponding plurality of sockets43 and aperture 65 located in jaw member 42. Conductive seal surface 116includes an extension 155 having a wire crimp 119 which engages thedistal end 91 of prong 103 and electrically engages a corresponding wireconnector affixed to wire 62 located in housing 71. Seal surface 116also includes an opposing face 115 which conducts an electrosurgicalcurrent to a tubular vessel or tissue 150 when it is held thereagainst.Alternatively, electrodes 110 and/or 120 can be formed as one piece andinclude similar components for insulating and conducting electricalenergy.

As best seen in FIG. 7, substrate 111 also includes an extension 108 anda stop member 106 which is designed to engage corresponding extension155 and an interface 107 located on conductive seal 116. To assembleelectrode 110, stop member 106 and extension 108 are overmolded ontointerface 107 and extension 155 of conductive seal 116. After assembly,wire crimp 119 is then inserted into end 91 of prong member 103 andconnected to wire 62.

It is known that as the tissue is compressed and electrosurgical energyis applied to the tissue, the impedance of the tissue decreases as themoisture level decreases. As a result, two mechanical factors play animportant role in determining seal thickness and effectiveness, i.e.,the pressure applied between opposing faces 47 and 45 and the gapdistance between the opposing electrodes 110 and 120 (see FIG. 5). Jawmembers 42 and 44 are configured to provide for the opposing electrodes110 and 120 to be in a desired gap range (e.g., 0.001 and 0.006 inches)at the end of the tissue sealing process (See FIG. 8). The materialconditions and components relating to the assembly of the electrodeassembly 21 and the mechanical forceps 20 are configured to fall withinspecific manufacturing tolerances to assure that the gap betweenelectrodes will not vary outside the desired range.

It is also known that tissue thickness is very difficult to control byforce alone, i.e., too much force and the two poles would touch and thelittle energy would travel through the tissue resulting in a bad seal ortoo little force and the seal would be too thick. Applying the correctforce is important for other reasons: to oppose the vessel lumens;reduce the tissue impedance to a low enough value that allows enoughcurrent through the tissue; and to overcome the forces of expansionduring tissue heating in addition to contributing towards creating therequired end tissue thickness which is an indication of a good seal.

It is also known that the size of the gap effects the tissue seal. Forexample, if a gap is too great, i.e., the jaws do not compress thetissue enough, the tissue does not properly liquefy the collagen foreffective sealing. If, on the other hand, the gap is too small, i.e.,the jaws compress the tissue too much, the electrosurgical energyeffectively severs the tissue which is also undesirous. It has beenfound that in order to effectively seal tissue and overcome theshortcomings described above, the gap distance (range) 151 (See FIG. 8)between the opposing electrodes 110 and 120 is preferably between about0.001 inches to about 0.006 inches and more preferably, between about0.002 inches to about 0.005 inches.

In order to assure that the desired gap range is achieved after assemblyand that the correct force is applied to seal the tissue, substrate 111includes at least one stop member, 106, which is designed to restrictand/or regulate movement of the two electrodes 110 and 120 relative toone another. Preferably, forceps 20 also includes at least one stopmember, e.g., 101 (see FIG. 3), for restricting and/or regulating thedistance between end effectors 22 and 24 and/or the closure forceapplied between opposing inner facing surfaces 47 and 45 of endeffectors 22 and 24 which will, in turn, regulate the distance betweenelectrodes 110 and 120. Since stop 106 is part of the disposableelectrode assembly 21, this stop has the added benefit of beingdependent on the material of the disposable electrode assembly 21.Preferably, a “step” stop is utilized due to its ease of manufacture andsimplicity.

It is contemplated that the stop member can be positioned at variouspoints along the disposable electrode assembly to achieve theaforedescribed desired gap range and/or the stop member can bepositioned on other parts of the instrument, e.g., handles 16, 18, jaws42, 44, and/or shafts 12, 14.

Preferably, the seal surfaces 115 and 125 are relatively flat to avoidcurrent concentrations at sharp edges and to avoid arcing between highpoints. In addition and due to the reaction force of the tissue 150 whenengaged, jaw members 42 and 44 are preferably manufactured to resistbending. For example and as best seen in FIG. 3, the jaw members 42 and44 and the corresponding electrodes 110 and 120 are preferably taperedalong width “W” which is advantageous for two reasons: 1) the taper willapply constant pressure for a constant tissue thickness at parallel; 2)the thicker proximal portion of the electrode, e.g., 110, will resistbending due to the reaction force of the tissue 150. The tapered shapeof the electrode, e.g., 110, is determined by calculating the mechanicaladvantage variation from the distal to proximal end of the electrode 110and adjusting the width of the electrode 110 accordingly.

Preferably, at least one of the prong members, e.g., 105, is resilientor includes a flex relief portion 53 which permits movement of the twoprong members 105 and 103 and, thus, the two electrodes 120 and 110,relative to one another. As seen best in FIG. 3, the electrode assembly21 is removably attached to the mechanical forceps 20 by initiallymoving prong 105 towards prong 103 by bending prong 105 at flex reliefportion 53. The electrodes 110 and 120 are then slid between opposingjaw members 42 and 44 in their open position such that detents 112 and122 and guide pins 126 and 124, respectively, are each disposed inalignment with each corresponding socket 43 and 41 or aperture 65 and67, respectively. Housing 71 is also positioned accordingly such thatshaft 14, handle 18 and pivot 25 are all positioned proximate theircorresponding channels 137, 139 and 133 located within housing 71.

When flex relief portion 53 is released, each electrode 110 and 120 isengaged with jaw member 42 and 44, respectively, i.e., detents 112, 122engage sockets 43, 41, and housing 71 is engaged with mechanical forceps20. The cover plate 80 is then attached to housing 71 in the mannerdescribed above. The bipolar forceps 10 is now ready for operation.

In one embodiment, the electrode assembly 21 is attached to themechanical forceps 20 in a different manner: For example and as bestillustrated in FIG. 3, the electrode assembly 21 can be engaged with themechanical forceps 20 in the following four-step manner: 1) electrodeassembly 21 and cover plate 80 are pivoted backward such that tang 99engages a slot 100 in electrode assembly 21; 2) electrode assembly 21and cover plate 80 are then pivoted forward to engage shaft 14 ofmechanical forceps 20 therebetween; 3) detents 112 of electrode 110 arethen engaged with sockets 43 of jaw member 22; and 4) detents 122 ofelectrode 120 are engaged with sockets 41 of jaw member 24.

In another embodiment, the electrode assembly 21 engages the forceps 20by way of a slide-on assembly technique. More particularly, the slide-onversion includes a series of keyhole-like apertures 541 disposed in theend effectors 22 and 24 which slidingly engage the correspondingmechanical interfaces 112, 122 and 124 extending from the insulators 111and 121, respectively. It is envisioned that the slide-on attachmentfeature facilitates removal and replacement of the electrode assembly 21and reduces manufacturing costs by minimizing the critical tolerances ofthe detents 112, 122 and alignment pins 126.

Further, it is contemplated that a slide-on assembly method compared toa snap-on assembly method may improve reliability of the forceps 20 dueto less plastic deformation at assembly. For example, the snap-ontechnique requires deformation of the fork-like detents 112, 122 topromote secure engagement of the electrode assembly 21 with the endeffectors 22 and 24. As can be appreciated, the less aggressive,slide-on technique reduces material deformation during assembly which,in turn, may lengthen the overall life of the instrument, preventslippage of the electrode assembly 21 and prevent separation of theelectrode assembly 21 during activation.

Further, it is contemplated that even though the slide-on assemblytechnique may engage the electrode assembly 21 in a less aggressivemanner during assembly, the uniquely-designed key-like interface 541,once engaged, provides a more aggressive connection which contributes tobetter “seating” of the electrode assembly 21 within the end effectors22 and 24. Again, the more aggressive seating of the electrode assembly21 prevents slippage of the electrode assembly 21 and preventsseparation of the electrode assembly 21 during activation.

FIG. 8 shows the bipolar forceps 10 during use wherein the handlemembers 16 and 18 are moved closer to one another to apply clampingforce to the tubular tissue 150 to effect a seal 152 as shown in FIGS. 9and 10. Once sealed, the tubular vessel 150 can be cut along seal 152 toseparate the tissue 150 and form gap 154 therebetween as shown in FIG.11.

After the bipolar forceps 10 is used or if the electrode assembly 21 isdamaged, the electrode assembly 21 can be easily removed and/or replacedby reversing the above attachment procedure and a new electrode assembly21 can be engaged with the mechanical forceps 20 in the same manner. Forexample, the electrode assembly 21 can be disengaged from the mechanicalforceps 20 in the following four-step manner: 1) the detents 122 ofelectrode 120 are disengaged from the sockets 41 of jaw member 24; 2)the detents 112 of electrode 110 are disengaged from the sockets 43 ofjaw member 22; 3) the electrode assembly 21 and cover plate 80 aredisengaged from shaft 14 of 19 mechanical forceps 20; and 4) theelectrode assembly 21 and cover plate 80 are pivoted such that tang 99disengages from slot 100 in electrode assembly 21.

It is envisioned that by making the electrode assembly 21 disposable,the electrode assembly 21 is less likely to become damaged since it isonly intended for a single use and, therefore, does not require cleaningor sterilization. As a result, the functionality and consistency of thevital sealing components, e.g., the conductive surface 126, 116 andinsulating surface 121, 111 will assure a uniform and quality seal.

FIGS. 12-14 show another embodiment of the present disclosure for usewith endoscopic surgical procedures and includes a bipolar forceps 210having a drive rod assembly 211 coupled to a handle assembly 218. Thedrive rod assembly 211 includes an elongated hollow shaft portion 212having a proximal end 216 and a distal end 214. An end effector assembly222 is attached to the distal end 214 of shaft 212 and includes a pairof opposing jaw members 280 and 282. Preferably, handle assembly 218 isattached to the proximal end 216 of shaft 212 and includes an activator220 for imparting movement of the jaw members 280 and 282 from an openposition wherein the jaw members 280 and 282 are disposed in spacedrelation relative to one another, to a clamping or closed positionwherein the jaw members 280 and 282 cooperate to grasp tissue 150therebetween.

As best seen in FIG. 13, activator 220 includes a movable handle 226having an aperture 234 defined therein for receiving at least one of theoperator's fingers and a fixed handle 228 having an aperture 232 definedtherein for receiving an operator's thumb. Movable handle 226 isselectively moveable from a first position relative to fixed handle 228to a second position in closer proximity to the fixed handle 228 toclose jaw members 280 and 282. Preferably, fixed handle 228 includes achannel 227 which extends proximally for receiving a ratchet 230 whichis coupled to movable handle 226. This structure allows for progressiveclosure of end effector assembly 222 as well as locking engagement ofopposing jaw members 280 and 282. In some cases it may be preferable toinclude other mechanisms to control and/or limit the movement of handle226 relative to handle 228 such as, e.g., hydraulic, semi-hydraulicand/or gearing systems.

Fixed handle 228 includes a rotating assembly 223 for controlling therotational movement of end effector assembly 222 about a longitudinalaxis “A” of the elongated shaft 212. Preferably, rotating assembly 223includes upper and lower knob portions 224 a and 224 b, respectively,which releasably engage one another about a gear 252 which is attachedto shaft 212. A pair of handle sections 228 a and 2228 b engage oneanother by way of a plurality of mechanical interfaces to form fixedhandle 228. As best seen in FIG. 13, each handle section 228 a and 228 bis generally hollow such that a cavity 250 is formed therein for housingvarious internal components which make up the forceps 210. For example,cavity 250 houses a PC board 258 which controls the electrosurgicalenergy being transmitted from an electrosurgical generator (not shown)to each jaw member 280 and 282. More particularly, electrosurgicalenergy is generated from an electrosurgical generator and transmitted tothe PC board by cable 260 which attached through a wire port 229disposed in the proximal end of handle assembly 218. The PC board 258converts the electrosurgical energy from the generator into twodifferent electrical potentials which are transmitted to each jaw member280 and 282 by a separate terminal clip 264 b and 264 a, respectively,which will be explained in more detail below with respect to FIG. 14.

Referring to FIG. 14, rod assembly 211 includes a drive rod 270 whichhas a proximal end 271 and a distal end 272. A piston 238 is attached tothe proximal end 271 of drive rod 270 and includes a generally roundedhead portion 239 and a notch 241 located between the head portion 239and the proximal end of piston 238. Preferably, clevis flanges 249 a and249 b of arm 240 are dimensioned to receive head 239 therebetween whenarm 240 is assembled between handle sections 228 a and 228 b (see FIG.6). Movement of the handle 226 towards fixed handle 228 imparts pivotalmovement of the upper end 245 of arm 240 at a pivot point 255 which, inturn, imparts movement of the piston 238 from a first position whereinthe piston 238 is disposed further from end effector assembly 222 to asecond position wherein piston 238 is in closer proximity to endeffector assembly 222. As explained in greater detail below, movement ofthe piston 238 between first and second positions imparts linearmovement to drive rod 270 which, in turn, moves jaw members 280 and 282toward and away from each other.

Seating the generally rounded head 239 between clevis flanges 249 a and249 b enables the user to utilize the rotating assembly 223 effectivelywithout interfering with the linear movement of the piston 238.

The end effector assembly 222 includes first jaw 280, second jaw 282 andan electrically insulating yoke 284 disposed therebetween. Preferably,jaw member 280 and jaw member 282 are movable from an open position to aclosed position by movement of the handle assembly 218 as describedabove. It is contemplated that either both or one of the jaw members 280and 282 can be movable relative to one another. First jaw member 280 hasa first flange 281 which extends therefrom and a cam slot 86 locatedtherethrough. Likewise, second jaw 282 has a second flange 283 whichextends therefrom and a cam slot 288 located therethrough.

The end effector assembly 222 also includes an outer nose portion 294and an inner nose portion 296 which engage jaw members 282 and 280,respectively. A first pivot 305 is located on outer nose portion 294 andis dimensioned to engage a corresponding pivot hole 289 located onflange 283. A second pivot 303 is located on inner nose portion 296 andis dimensioned to engage a corresponding pivot hole 287 located onflange 281. The center of rotation for first jaw member 280 is at afirst pivot hole 287 and the center of rotation for second jaw member282 is at a second pivot hole 289. Preferably, each nose portion 294 and296 is made from an electrically conductive material and transmitselectrosurgical energy to a respective jaw member 282 and 280 asdescribed in more detail below.

As mentioned above with respect to FIG. 13, electrosurgical energy istransmitted from the electrosurgical generator to a connector assembly315 which includes the PC board 258 which converts the energy into firstand second plates. A pair of terminal clips 264 a and 264 b areconnected to PC board 258 and transfer the first and second poles ofalternating potential, respectively, to the drive rod assembly 211. Clip264 a connects to shaft 212 and conducts the first pole to jaw member282 and clip 264 b connects to piston 238 which is, in turn, connectedto drive rod 270. The second pole is conducted along drive rod 270 tojaw member 280. Both the drive rod 270 and the shaft 212 are made froman electrically conductive material and preferably an insulation sleeve275 is disposed between drive rod 270 and shaft 212 to prevent theforceps 210 from short circuiting.

As best seen in FIG. 14, the inner nose portion 296 is electricallyconnected with drive rod 270 and the outer nose portion 294 iselectrically connected to shaft 212. The inner and outer nose portions296 and 294 capture yoke 284 along with flanges 283 and 281. Yoke 284moves axially along axis “A” in a space between inner and outer portions296 and 294 and a spacer stake 319 maintains the separation of the noseportions 296 and 294 at their distal ends. Stake 319 is dimensioned toengage and lock the inner and outer nose portions 296 and 294 together,which, in turn locks jaw members 280 and 282 atop yoke 284. In somecases it may be preferable to dimension stake 319 such that stake 319acts as a stop member and C0(ltrols the gap distance between theopposing jaw members 280 and 282 relative to one another. In this case,stake 319 is formed from an electrically insulative material such asplastic. The nose portions 294 and 296 provide lateral support for theflanges 281 and 283 and help ensure that detents 290 and 292 remainwithin cam slots 286 and 288, respectively.

End effector assembly 222 also includes an inner insulator 302 and anouter insulator 300 for maintaining electrical insulation between poles.Outer insulator 300 insulates outer nose portion 294 from inner noseportion 296 and drive rod 270 which conduct the second pole ofelectrical energy Inner insulator 302 insulates inner nose portion 296from outer nose portion 294 and shaft 212 which conduct the first poleof electrical energy. In this manner, outer nose portion 294 can provideelectrical continuity between shaft 212 and jaw member 282, while innernose portion 296 can provide electrical continuity between drive rod 270and jaw member 280.

Preferably, a spring contact 298 is utilized to maintain the electricalconnection between drive rod 270 and inner nose portion 296 during axialmotion of the drive rod 270. A donut-shaped spacer 308 can also beutilized to assure linear motion of the drive rod 270 within sleeve 275and to prevent accidental short circuiting of the forceps 210.

Referring back to FIG. 14, yoke 284 is preferably formed from anelectrically insulative material such as plastic. A first side 291 ofyoke 284 faces first flange 281 and a second side 293 of yoke 284 facessecond flange 283. When yoke 84 is positioned between flanges 281 and283, yoke 284 electrically insulates first jaw member 80 from second jawmember 282. In this manner, bipolar electrosurgical current can beconducted through tissue 350 which is grasped between jaws 280 and 282without flanges 281 and 283 short circuiting.

In order to achieve a desired gap range (e.g., about 0.001 to about0.006 inches and, preferably, about 0.002 inches to about 0.003 inches)and apply a desired force to seal the tissue, at least one jaw member280 and/or 282 includes a stop member 339 which limits the movement ofthe two opposing jaw members 280 and 282 relative to one another. Asexplained above, in some cases it may be preferable to dimension stake319 such that it acts like a stop member and limits the movement of thetwo opposing jaw members 280 and 282 relative to one another.Preferably, stop member 339 and/or stake 3′19 is made from an insulativematerial and is dimensioned to limit opposing movement of the jawmembers 280 and 282 to within the above gap range.

In another embodiment, the stop members may be dimensioned for selectiveand replaceable attachment to the jaw members depending upon aparticular purpose. For example and as best shown in FIGS. 15A-15C, thestop members may be dimensioned as plugs 439 which selectively attach tothe inner facing surfaces 115 and 125 of the jaw members through aseries of apertures 441 and 443 defined through the inner surfaces 115,125 and insulators 116, 126, respectively. The gap plugs 439 arepreferably designed for snap-fit engagement through the apertures 441and 443 of at least one of the jaw members, e.g., and are dimensioned toprotrude a distance “R” from the inner surfaces 125 thereof (FIG. 15C).As can be appreciated, the gap plugs 439 create minimum gap distance “G”(FIG. 8} between opposing inner facing surfaces 115 and 125 when the jawmembers 110 and 120 cooperate to grasp tissue therebetween.

It is envisioned that a user may selectively engage one or more gapplugs 439 as needed to create a desired gap distance between the jawmembers 110 and 120 during manipulation and/or sealing. As can beappreciated, the overall gap distance “G” is easily and selectivelyvariable through substitution/replacement of a particularly-sized gapplug.

Preferably, the stop members 139, 239, 339 and/or 439 are made from aninsulative material, e.g., parylene, nylon and/or ceramic and aredimensioned to limit opposing ‘movement of the jaw members 110 and 120to within a specified gap range. It is envisioned that the stop members139, 239, 339 and/or 439 may be disposed one or both of the jaw members110 and 120 depending upon a particular purpose or to achieve aparticular result. Preferably, the stop members 139, 239, 339 and/or 439may be configured in any known geometric or polynomial configuration,e.g., triangular, rectilinear, circular, ovoid, scalloped, etc.,depending upon a particular purpose. Moreover, it is contemplated thatany combination of different stop members 139, 239, 339 and/or 439 maybe assembled along the sealing surfaces 115 and 125 to achieve a desiredgap distance. Preferably, the non-conductive stop members 139, 239, 339and/or 439 are molded onto the jaw members 110 and 120 (e.g.,overmolding, injection molding, etc.), stamped onto the jaw members 110and 120 or deposited (e.g., deposition) onto the jaw members 110 and120. The stop members 139, 239, 339 and/or 439 may also be slideablyattached to the jaw members and/or attached to the electricallyconductive surfaces 115 and 125 in a snap-fit manner.

Other techniques for attaching the stop members 139, 239, 339 and/or 439are also contemplated. For example, one technique involves thermallyspraying a ceramic material onto the surface of the jaw member 110 and120 to form the stop members 139, 239; 339 and/or 439. Several thermalspraying techniques are contemplated which involve depositing a broadrange of heat resistant and insulative materials on the electricallyconductive surfaces 115 and 125 to create stop members 139, 239, 339and/or 439, e.g., High velocity Oxy-fuel deposition, plasma deposition,etc.

From the foregoing and with reference to the various figure drawings,those skilled in the art will appreciate that certain modifications canalso be made to the present disclosure without departing from the scopeof the present disclosure. For example, although it is preferable thatelectrodes 110 and 120 meet in parallel opposition, and, therefore, meeton the same plane, in some cases it may be preferable to slightly biasthe electrodes 110 and 120 to meet each other at a distal end such thatadditional closure force on the handles 16 and 18 is required to deflectthe electrodes in the same plane.

Although it is preferable to vertically align electrodes 110 and 120, insome cases it may be preferable to offset the opposing electrodes 110and 120 relative to one another either longitudinally or transversallyto suit a particular purpose.

Although it is preferable that the electrode assembly 21 include housing71 and cover plate 80 to engage mechanical forceps 20 therebetween, insome cases it may be preferable to manufacture the disposable electrodeassembly 21 such that only one piece, e.g., housing 71 is required toengage mechanical forceps 20.

While only one embodiment of the disclosure has been described, it isnot intended that the disclosure be limited thereto, as it is intendedthat the disclosure be as broad in scope as the art will allow and thatthe specification be read likewise. Therefore, the above descriptionshould not be construed as limiting, but merely as exemplifications of apreferred embodiment. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

1-8. (canceled)
 9. A bipolar electrosurgical instrument for sealingvessels, comprising: a handle assembly including a movable handle andfixed handle; a shaft having a longitudinal axis, the shaft coupled tothe handle assembly and extending distally therefrom; first and secondjaw members disposed at a distal end of the shaft; the movable handlemovable relative to the fixed handle from a first position, wherein thefirst and second jaw members are disposed in spaced relation relative toone another, to a second position, wherein the first and second jawmembers are closer to one another; a first tissue sealing surfaceassociated with the first jaw member and a second tissue sealing surfaceassociated with the second jaw member, wherein movement of the movablehandle from the first position to the second position results in thefirst and second tissue sealing surfaces being in a closed position suchthat they reside in opposing facing relation to one another; at leastone stop member associated with at least one of the tissue sealingsurfaces for controlling a gap between the opposing tissue sealingsurfaces in the closed position to be within a range from 0.001 to 0.006inches such that, upon electrosurgical activation of an electrosurgicalenergy source, tissue grasped between the tissue sealing surfaces sealsinto a fused mass; a rotating assembly coupled to the shaft, therotating assembly operable to rotate the first and second jaw membersabout the longitudinal axis; a ratchet associated with the handleassembly and operable to maintain the first and second tissue sealingsurfaces in the closed position; and a connector coupled to the handleassembly, the connector operable to electrically connect the first andsecond tissue sealing surfaces to the electrosurgical energy source suchthat one of the tissue sealing surfaces has a first electrical potentialand the other tissue sealing surfaces has a second electrical potentialsuch that the first and second tissue sealing surfaces are capable ofconducting bipolar energy through tissue grasped therebetween in theclosed position.
 10. The bipolar electrosurgical instrument according toclaim 9, wherein the first jaw member is fixed.
 11. The bipolarelectrosurgical instrument according to claim 9, wherein at least one ofthe jaw members includes an insulating substrate.
 12. The bipolarelectrosurgical instrument according to claim 11, wherein the at leastone stop member is engaged with the insulating substrate.
 13. Thebipolar electrosurgical instrument according to claim 9, wherein the atleast one stop member is formed from an insulative material.
 14. Thebipolar electrosurgical instrument according to claim 9, wherein atleast one of the jaw members includes an electrical connector forcoupling to a wire.
 15. The bipolar electrosurgical instrument accordingto claim 9, wherein the fixed handle comprises a channel configured toreceive the ratchet.
 16. The bipolar electrosurgical instrumentaccording to claim 15, wherein the channel curves upward toward thelongitudinal axis of the shaft.
 17. The bipolar electrosurgicalinstrument according to claim 9, wherein the movable handle includes anaperture defined therein operable by a user to move the movable handlebetween the first and second positions.